Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Easier, Noninvasive Diagnosis of Neurological Disorders
More companies have begun offering neurofilament light chain blood tests as a cost-effective alternative to conventional methods.
Roche Scores First European IVDR Approval for Diagnostic Tests
The test manufacturer is the first to gain IVDR certification for a companion diagnostic under the new regulation.
Early in Pandemic, HIV Testing Dropped Sharply, but Quickly Rebounded
A recent CDC report concludes that disruptions to HIV testing due to the COVID-19 pandemic compromised America’s ability to prevent the disease.
Weekly Enforcement Report: Medical Equipment & Kickbacks
While labs were absent from recent enforcement actions, last week saw kickback schemes involving DME companies and a medical device company.
CMS to Crack Down on False Billing of COVID-19 Add-on Tests
Some labs took advantage of COVID coverage rules to bill Medicare for medically unnecessary RPPs, allergy, and genetic tests.
New Cancer Diagnostic Tests Stand Out
Key Dx announcements last week involved companion diagnostics, liquid biopsy assays, and an RUO leukemia test.
Clinical Laboratory Enforcement Update
Get an overview of trending areas of enforcement and steps labs and pathology practices can consider to protect their businesses.
The Promise of Mobile Photoacoustic Imaging
The flexibility of compact, mobile, photoacoustic imaging equipment on wheels is helping to advance groundbreaking medical research, diagnostics, and treatment.
COVID-19, Genetic Tests Wipe Out Medicare Part B Lab Test Savings
Even though PAMA has slashed reimbursement rates for many tests, overall Medicare Part B spending on lab tests continues to increase.
Empowered Dx in Hot Water with FDA Again Over COVID-19 Test Kits
At the end of 2022, the agency sent a new warning letter to Empowered for unauthorized distribution of COVID-19 test kits.
